21 CFR § 522.1014 - Gamithromycin.

---
identifier: "/us/cfr/t21/s522.1014"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.1014 - Gamithromycin."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.1014"
section_name: "Gamithromycin."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 522.1014 Gamithromycin.

(a) *Specifications.* Each milliliter (mL) of solution contains 150 milligrams (mg) gamithromycin.

(b) *Sponsor.* See Nos. 000010 and 061133 in § 510.600(c) of this chapter.

(c) *Related tolerances.* See § 556.292 of this chapter.

(d) *Conditions of use*—(1) *Cattle*—(i) *Amount.* Administer 6 mg/kilogram of body weight (2 mL per 110 pounds) one time by subcutaneous injection in the neck.

(ii) *Indications for use.* For the treatment of bovine respiratory disease (BRD) associated with *Mannheimia haemolytica, Pasteurella multocida,* *Histophilus somni,* and *Mycoplasma bovis* in beef and non-lactating dairy cattle; and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with *M. haemolytica* and *P. multocida.*

(iii) *Limitations.* Cattle intended for human consumption must not be slaughtered within 35 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[76 FR 57906, Sept. 19, 2011, as amended at 77 FR 26162, May 3, 2012; 84 FR 39184, Aug. 9, 2019; 91 FR 5301, Feb. 6, 2026]